The Role of Statisticians in Clinical Trials
Author Information
Author(s): Jaykaran Chavda, N Yadav
Primary Institution: Govt. Medical College, Surat, India
Hypothesis
Does the inclusion of a statistician significantly improve the reporting of statistical parameters in clinical trials?
Conclusion
The study found that including a statistician mainly improves the reporting of sample size and number of primary endpoints, but does not significantly enhance other statistical parameters.
Supporting Evidence
- The role of a statistician was acknowledged in 19.1% of the trials analyzed.
- Of the trials with a statistician, 61.5% were positive outcomes.
- Statistically significant differences were found in sample size and number of primary endpoints between trials with and without a statistician.
Takeaway
This study looked at how having a statistician helps in clinical trials, and found that they mostly help with figuring out how many people should be in the study and how many main results there are.
Methodology
The study analyzed clinical trials published in four Indian medical journals over nine years, focusing on the role of statisticians and various statistical parameters.
Potential Biases
There may be under-reporting of the role of statisticians in the trials.
Limitations
The study's limitations include a small sample size and uncertainty about when statisticians contributed to the trials.
Participant Demographics
Clinical trials from Indian medical journals.
Statistical Information
P-Value
0.019
Confidence Interval
95% CI: 11.5%-30%
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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